# KETOTIFEN FUMARATE
> **ANDA077958** · Abbreviated New Drug Application (Generic) · Sponsor: SENTISS · Approved 2007-07-26
## Drug
- **FDA Application Number:** ANDA077958
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** KETOTIFEN FUMARATE
- **Generic name:** KETOTIFEN FUMARATE
- **Active ingredients:** KETOTIFEN FUMARATE
- **Dosage form:** SOLUTION/DROPS
- **Route:** OPHTHALMIC
- **Marketing status:** Over-the-counter
- **Sponsor:** SENTISS
- **Manufacturer:** Sentiss Pharmaceuticals LLC
- **First approval:** 2007-07-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077958)
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